Are you a manufacturer of medical devices and need an overview or have specific questions about approval, reimbursement or testing? Do you need a quality management system according to EN ISO 13485? The complexity of regulatory requirements harbours the risk of getting lost and taking the wrong path.
BEO BERLIN helps you to define the next steps and explains what must not be overlooked.
ISO/CD 18562-4 (Project)
DIN EN ISO 10651-5 (Draft)
DIN EN ISO 5361 (Draft)
DIN EN ISO 20126 (Draft)
ISO 20417:2021
ISO 80601-2-87:2021
The guideline issued by the FDA is regulatory flexibility, including a temporary waiver of the premarket notification requirements under Section 510 (k) of the Food, Drug, and Cosmetic Act.
Will applications for export certificates and confirmations be possible only for economic operators based in Switzerland assuming the role of manufacturer or Authorised Representative?
The MDCG has recently published helpful documents. Is your software a medical device? Is it actually a custom-made device?
When the HMV Application Gets Lost in Tranlation: dealing with the first response to your application from the GKV.
Uncertainty and questions in regards to „How and where do I obtain a UDI“ have been frequently brought to us in recent months. In a short overview we will show you possible way and provide you with relevant links to for further reading.
DIN EN ISO 8836
DIN EN ISO 3630-1 (project)
ISO/TS 37137-1:2021
German version of EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterisation of materials was published this month and replaces the version from 2009.
